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Patient-reported outcomes in relapsed/refractory multiple myeloma: a systematic review

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Abstract

Purpose

We performed a systematic review to quantify the amount of evidence-based data available on patient-reported outcomes (PRO) in Relapsed/Refractory Multiple Myeloma (RRMM) patients and to examine the added value of such studies in supporting clinical decision-making.

Methods

We conducted a search in PubMed/Medline and the Cochrane Library to identify studies published between January 1990 and May 2017. All studies, regardless of the design, including patients with RRMM and also evaluating PRO were considered. For each study, we collected both PRO and traditional clinical outcomes, such as survival and toxicity information, based on a predefined data extraction form.

Results

After having screened 1680 records, 11 studies were identified and these included six randomized controlled trials (RCT). Overall, there were five studies focusing on proteasome inhibitors (PIs), four on immunomodulatory drugs (IMiDs), one on both PIs and IMiDs, and one on monoclonal antibodies. Considering only RCTs, it was found that primary clinical efficacy endpoints frequently favored experimental arms, while (physician-reported) toxicity data did not. However, inspection of PRO data revealed novel information that often contrasted with standard toxicity, for example, by not indicating worse quality of life outcomes or symptom severity for patients enrolled in the experimental arms.

Conclusions

There is paucity of evidence-based data regarding the impact of therapies on quality of life and symptom burden of patients with RRMM. Inclusion of PRO in future studies of patients with RRMM is needed to better inform clinical decision-making.

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Acknowledgments

We thank Alissa Haas and Lauren Fitz for their editorial assistance in the preparation of this manuscript.

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Authors and Affiliations

  1. Italian Group for Adult Hematologic Diseases (GIMEMA), Data Center and Health Outcomes Research Unit, Via Benevento, 6, 00161, Rome, Italy

    Francesco Sparano & Fabio Efficace

  2. Institute of Hematology “L. and A. Seràgnoli”, Department of Experimental, Diagnostic and Specialty Medicine, “S.Orsola-Malpighi” University Hospital, University of Bologna, Bologna, Italy

    Michele Cavo

  3. Hematology Unit, S Eugenio Hospital, Rome, Italy

    Pasquale Niscola & Tommaso Caravita

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  1. Francesco Sparano
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Correspondence to Fabio Efficace.

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Conflict of interest

FE: Research funding (Lundbeck, TEVA and Amgen); Consultant/Advisory Role (Bristol-Myers Squibb, Seattle Genetics, TEVA and Incyte)

MC: Remuneration (Janssen, Celgene, Amgen, Takeda, Bristol-Myers Squibb), Consultant/Advisory Role (Janssen, Celgene, Amgen, Takeda, Bristol-Myers Squibb)

TC: Consultant/Advisory Role (Janssen-Cilag, Celgene, Amgen, Takeda, Bristol-Myers Squibb)

The remaining authors have no conflicts of interest.

I have full control of all primary data and I agree to allow the journal to review their data if requested.

Appendix 1

Appendix 1

(“quality of life” OR “health-related quality of life” OR “health status” OR “health outcomes” OR “patient outcomes” OR “depression” OR “anxiety” OR “emotional” OR “social” OR “psychosocial” OR “psychological” OR “distress” OR “social” OR “social functioning” OR “social well-being” OR “patient-reported symptom” OR “patient-reported outcomes” OR pain OR fatigue OR “patient-reported outcome” OR “PRO” OR “PROs” OR “HRQL” OR “QOL” OR “HRQOL” OR “symptom distress” OR “symptom burden” OR “symptom assessment” OR “functional status” OR “performance status” OR nausea OR functioning OR vulnerability OR fragility OR bone OR bone pain OR skeletal fracture OR weakness OR renal insufficiency OR anemia OR infections OR numbness OR tingling OR lesions OR hypercalcemia OR hyperviscosity OR bleeding) AND Myeloma AND (Relapsed OR Refractory).

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Sparano, F., Cavo, M., Niscola, P. et al. Patient-reported outcomes in relapsed/refractory multiple myeloma: a systematic review. Support Care Cancer 26, 2075–2090 (2018). https://doi.org/10.1007/s00520-018-4137-x

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